FDA 483 - Pharma Nobis LLC - March 13, 2020

Humco Holding Group, Inc., a drug manufacturer/repackager in Texarkana, TX, was cited for significant deficiencies across its quality, laboratory, facilities, materials, and production systems. The inspection revealed widespread issues including inadequate investigations into out-of-specification results, lack of proper stability testing programs and documentation, deficient laboratory records, and poorly defined cleaning procedures. Additionally, the firm failed to adequately qualify suppliers and ensure proper testing of incoming active pharmaceutical ingredients.